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The choice and definition of the grade of water to be used should be based on the EMA “Guideline “Guideline on the quality of water for pharmaceutical use (EMA/CHMP/CVMP/QWP/496873/2018)” and the relevant Ph. Eur. monographs, namely potable water, purified water, water for injections or water for preparation of extracts. Terms such as deionised water, process water, drinking water, reverse osmosis water, distilled water, etc. should not be used as they are not referenced in the EMA guideline.
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